Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C2 Therapeutics — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150083 | Sidecar External Working Channel | C2 Therapeutics | 2015-04-14 | 89 | 0 |
| K131523 | CRYOBALLOON FOCAL ABLATION SYSTEM | C2 Therapeutics | 2013-08-22 | 86 | 2 |
| K101825 | CRYOBALLOON ABLATION SYSTEM | C2 Therapeutics | 2010-09-29 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda